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The Childhood Health and Asthma Management Program (CHAMP)

16. mai 2017 oppdatert av: University of Florida

Overweight and obese (OV/OB) children with asthma are at-risk for particularly poor health outcomes including poor asthma control, higher risk of asthma-related symptoms, and decreased quality of life. Weight loss reduces asthma symptoms, improves lung function, and increases quality of life among OV/OB adults with asthma. Little research has examined the impact of weight loss on asthma outcomes in OV/OB youth, and there is little research examining weight management interventions in OV/OB children with asthma. Behavioral family-based lifestyle interventions are successful in producing weight loss in children. To our knowledge, however, there has been no systematic effort to examine the impact of these interventions on weight status and asthma outcomes, nor has there been an effort to tailor these programs to the specific needs of OV/OB children with asthma.

The aims of this study are to develop and test the Childhood Health and Asthma Management Program (CHAMP), a behavioral family-based lifestyle intervention that is community-based to promote successful weight and asthma management in OV/OB children with asthma. The investigators propose to develop an intervention based on a previously developed behavioral family-based lifestyle intervention that was community-based and produced positive long term weight status changes in OV/OB children and tailor it for OV/OB children with asthma to create CHAMP. CHAMP will include asthma education and targeting unique barriers to weight management in OV/OB children with asthma. A focus group will be conducted with OV/OB children with asthma, ages 6-12, and their parent(s). Then a pilot randomized controlled trial of the CHAMP intervention with 32 OV/OB children with asthma, ages 6-12 years, and their parent(s). Families will be randomly assigned to CHAMP or a health education group. The investigators hypothesize that participants in CHAMP will have more effective weight and asthma management and child asthma outcomes compared to those in the general education group.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

At the first appointment the following information will be collected to determine eligibility for the research study. If participation is determined, a second visit will be scheduled at the end of the visit or the potential participant will be provided with a suggestion to speak with their primary care physician for other treatment options.

A measurement of height and weight will be taken, questionnaires regarding medical history, including asthma symptoms and control, and questionnaires about family background information (e.g., family income, size of family, employment, and marital status).

In addition, information concerning the following conditions will be collected and may exclude participation: dietary restriction or a medical condition that makes mild energy restriction or physical activity potentially dangerous, diagnosed with a major psychiatric disorder such as schizophrenia, bipolar disorder or autism, has used systemic corticosteroids within 3 months, or prescription weight loss drugs within 6 months.

The second appointment will happen one to two weeks before the start of the treatment program. During this visit the following will happen:

A measurement of height and weight, and waistline, questionnaires and complete an interview about asthma management and quality of life, and a test for lung function both pre and post albuterol. At the end of the visit an accelerometer will be provided to wear for 7 days in a row. The accelerometer will measure how much exercise is done each day.

At the end of this visit, the participant will be randomly assignment to either the experimental Childhood Health and Asthma Management Program (CHAMP) group or the health education group.

The CHAMP group will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.

The health education group will receive tailored asthma education and general health education on a variety of topics.

Each of the treatment programs will last for 6 months.

Studietype

Intervensjonell

Registrering (Faktiske)

56

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Florida
      • Gainesville, Florida, Forente stater, 32610
        • University of Florida

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 år til 12 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • speaks English;

  • has a physician-verified persistent asthma diagnosis or by indicating on a screening questionnaire that they

    1. having a current prescription for a controller medication (e.g. Fluticasone), or
    2. demonstrating any of the following symptom frequency in the previous month: (I) daytime asthma symptoms more than two days a week, (II) nighttime awakenings due to asthma more than times a month, (III) short-acting beta agonist use 2 days a week, (IV) normal activity limitation, (V) oral steroid use 2 times a year, (VI) emergency department visit due to asthma in past year;
  • has a BMI at or above the 85th percentile for age and gender norms as published by the CDC.

Participating parents of legal guardians must:

  • live in the same home with the child;
  • speak English;
  • be aged 75 or younger. There is no BMI requirement for participating parents/legal guardians.

Exclusion Criteria:

  • child or parent has dietary restriction or a medical condition that contraindicates mild energy restriction or physical activity (history of musculo-skeletal condition that limits walking, heart condition, chronic lung diseases limiting physical activity, current participation in commercial weight loss program);
  • use of antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids within 3 months, or prescription weight loss drugs within 6 months.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CHAMP
Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
Atferdsmessig: CHAMP
Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
Aktiv komparator: Health education
Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.
Atferdsmessig: Health education
Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Spirometry will be used to test the change in lung function from baseline, 4 months, and 10 months
Tidsramme: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months

Sekundære resultatmål

Resultatmål
Tidsramme
Body Mass Index will be calculated to test the change in weight from baseline, 4 months, and 10 months
Tidsramme: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months
The Asthma Control Test questionnaire will be calculated to test the change in asthma control from baseline, 4 months, and 10 months
Tidsramme: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months
The Family Asthma Management System Scale semi-structured interview will be used to test the change in family asthma management from baseline, 4 months, and 10 months.
Tidsramme: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months
The Standardised Paediatric Asthma Quality of Life Questionnaire interview will be used to test the change in quality of life from baseline, 4 months, and 10 months.
Tidsramme: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months
The Block Foods questionnaire will be used to test the change in dietary intake from baseline, 4 months, and 10 months.
Tidsramme: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months
Objectively monitored physical activity will be used to test the change in physical activity from baseline, 4 months, and 10 months.
Tidsramme: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Florida

Samarbeidspartnere

American Lung Association

Etterforskere

  • Hovedetterforsker: David A Fedele, Ph.D>, University of Florida

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2014

Primær fullføring (Faktiske)

13. mars 2017

Studiet fullført (Faktiske)

13. mars 2017

Datoer for studieregistrering

Først innsendt

25. november 2014

Først innsendt som oppfylte QC-kriteriene

25. november 2014

Først lagt ut (Anslag)

1. desember 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2017

Sist bekreftet

1. mai 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB201400235

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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